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NDC 63824-0951-07 Mucinex Childrens 100; 2.5 mg/5mL; mg/5mL Details
Mucinex Childrens 100; 2.5 mg/5mL; mg/5mL
Mucinex Childrens is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 63824-0951-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 63824-0951-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0951 |
|---|---|
| Product ID | 63824-951_00ebb7e4-8722-474b-b66b-fd9e2d58ca0e |
| Associated GPIs | 43996202100915 |
| GCN Sequence Number | 063318 |
| GCN Sequence Number Description | guaifenesin/phenylephrine HCl LIQUID 100-2.5/5 ORAL |
| HIC3 | B4W |
| HIC3 Description | DECONGESTANT-EXPECTORANT COMBINATIONS |
| GCN | 99069 |
| HICL Sequence Number | 000250 |
| HICL Sequence Number Description | GUAIFENESIN/PHENYLEPHRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Childrens |
| Proprietary Name Suffix | Stuffy Nose and Chest Congestion |
| Non-Proprietary Name | Guaifenesin and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 100; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63824-0951-07 (63824095107)
| NDC Package Code | 63824-951-07 |
|---|---|
| Billing NDC | 63824095107 |
| Package | 1 BOTTLE in 1 CARTON (63824-951-07) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2018-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7354f57c-0ecf-481f-9482-0040c90c4350 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Directions
- do not give more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
| Age | Dose |
|---|---|
| children 6 to under 12 years of age | 10 mL every 4 hours |
| children 4 to under 6 years of age | 5 mL every 4 hours |
| children under 4 years of age | do not use |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Pediatrician Recommended†
NDC 63824-951-07
Mucinex®
Children's
STUFFY NOSE &
CHEST CONGESTION
Guaifenesin 100 mg - Expectorant
Phenylephrine HCl 2.5 mg - Nasal Decongestant
- ✔
- Relieves Stuffy Nose
- ✔
- Relieves Chest Congestion
- ✔
- Breaks up Mucus
- ✔
- Alcohol-free
Ages
4+
yrs
Very Berry
Flavor Liquid
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
| MUCINEX CHILDRENS
STUFFY NOSE AND CHEST CONGESTION
guaifenesin and phenylephrine hydrochloride solution |
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| Labeler - RB Health (US) LLC (081049410) |